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Enteral and Anesthesia ISO changes

Learn how BD is responding

Tubing misconnections of enteral nutrition (EN) into the wrong port or tube have been identified as a serious and potentially deadly issue.1 These misconnections have prompted the development of new international design standards for medical device tubing connectors.

BD takes patient safety very seriously, always placing the highest emphasis on the safety of our products. To continuously ensure it in our neuraxial and enteral solutions while meeting the new ISO standards, we are carefully considering the risks posed by the female ENFit® syringe and low-dose tip (LDT) designs based on the information available. In turn, we are pursuing a male enteral syringe design that complies with the ISO 80369-3 standard and meets the standard for dose accuracy defined in ISO 7886-1. BD is also committed to launching new anesthesia products that will comply with the ISO 80369-6 standard (NRFit™ connector).

ISO 80369-3: Connectors for enteral applications

BD offers the following resources to inform you of the updated ISO standards in relation to the ENFit connector. As enteral feeding touches a diverse patient population, the attached resources are applicable to the various enteral feeding environments including the NICU, PICU and ICU.

ISO 80369-6: Connectors for neuraxial applications

The scope of the changes to this standard encompasses more than 100 BD products. Therefore, we must carefully roll out the ecosystem to maintain continuity of patient care.

BD plans on launching the full ecosystem of compliant neuraxial products.

These product introductions will provide the capacity necessary to ensure a steady stream of products to all BD customers. The ISO anticipates a phased transition to the new design over a five-year period.* BD will continue to offer our existing range of products during this transition.


1 FDA website. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/default.htm

* Applicable law or regulations in your location may require a more accelerated transition.

BD-2559 (5/17)

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